UT4000AUT6000A Patient Monitors Service Guide

UT4000A UT6000A Patient Monitors SERVICE GUIDE

Release V6

English

UT4000A UT6000A Patient Monitors SERVICE GUIDE

Release V6

English

Important Information

Product Information Product models: UT4000A/UT6000A Product name: Patient Monitor

Standard The product is made under the ISO9001 and ISO13485 quality system certified by TUVPS. The product has passed the CE certification.

Manufacturer Information Shenzhen Goldway Industrial Inc. Goldway Building, No. 3 Road, North Section, Shenzhen High-Tech Industrial Park, Shenzhen, P.R. China 518057 Tel: +86 755 26980999 Fax: +86 755 26980222

Version First Edition: November 2009 Shenzhen Goldway Industrial Inc. All Rights Reserved.

Safety Conventions The guide uses the following conventions for Notes, Cautions, and Warnings.

Note — A Note calls attention to an important point in the text. Caution A Caution calls attention to a condition or possible situation that could damage or destroy the product or the user’s work.

Warning A Warning calls attention to a condition or possible situation that could cause injury to the user and/or patient.

i


Explanation of Symbols The following symbols appear on the monitor and its packaging. Table 1 Monitor Symbols

Symbol 0123

Description

Symbol

Description

CE mark

Fragile, handle with care

Recyclable

Keep upright

Recycle packaging

Maximum stacking

Humidity

Caution

Temperature

Atmospheric pressure

CF applied part: Connector has special protection against electric shocks and is defibrillator proof BF applied part: Connector has special protection against electric shocks and is defibrillator proof

Keep dry

Waveform freeze key

SpO2 probe connector

Alarm silence key

ECG connector

Print key (UT6000A only)

NIBP cuff connector

NIBP key

TEMP1

TEMP1 connector (UT6000A only)

On/off key

TEMP2

TEMP2 connector (UT6000A only)

AC Power LED

ECG menu key

Charging LED

SpO2 ECG/RESP

NIBP

ii

Important Information Table 1 Monitor Symbols (Continued) Manufacturer address

Equipotential grounding lug

EU representatives

Dangerous Voltage

Date of manufacture

Serial number

Consult Instructions for Use

IPX1

Protective grade

15V DC Power Input Port (UT4000A only)

USB port

Compliance with WEEE standard

Signal input and output

Protective grounding

Catalog number

Fuse

Batch code

Ethernet port

Option number

Regulatory and Safety Specifications Declaration

The UT4000A/UT6000A monitors are Class IIb devices and comply with the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and carry CE-marking accordingly.

Authorized EU Representative Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726

iii


Product Support and Warranty Information Warranty period for the UT4000A/UT6000A monitor is one year from the date of shipment. Warranty is parts only and does not include any labor. Shipping of replacement parts is included in the warranty. Warranty claims for parts require the return of the defective materials to Goldway. Accessories that are included with the product are warranted for 6 months from the date of shipment of the original product. Warranty for accessories is replacement. Keep the packing case for transport, storage, or maintenance. Goldway is responsible for the safety, reliability and performance of the monitor when the: •

Product is assembled, upgraded, altered, or maintained by authorized service representatives.

•

Monitor is located in a typical hospital environment.

•

Product is used according to this manual.

Goldway is not responsible for damage to the monitor when: •

Damage is caused by: –

Improper operation.

–

Improper connection of the monitor to other devices.

–

Accidental impact.

•

The monitor is altered without written authorization from Goldway.

•

The serial number of the monitor is removed or becomes illegible.

iv


After Sales Service When you need product support: 1. Contact your local Goldway representative. 2. For further support, contact Goldway’s Customer Service Department: Customer Service Department of Shenzhen Goldway Industrial Inc. Goldway Building, No. 3 Road, North Section, Shenzhen High-Tech Industrial Park, Shenzhen, P. R. China 518057 The international call center hous: Monday – Friday (Except Chinese statutory holidays) BJT 08:30-12:00, 13:00-17:30 (GMT+8) Tel: +86 755 86278308 Fax: +86 755 86278392 E-mail: [email protected] Service and support are available in Chinese and English only. Primary repair strategy: Assembly/component replacement Secondary repair strategy: Return for repair (to International bench repair) Before calling for service, note the following information: •

Model and serial number of the monitor

•

Monitor problem

Safety Standards Table 2 Safety Standards

Parameter Protection Class Degree of Protection

Specification Class I, anti-shock, externally and internally powered equipment, per IEC 60601-1 • Type CF and BF defibrillator-proof: per IEC 60601-1 • Degree of noxious-liquid proof as IPX1 • Anti-shock degree as combination of BF and CF applied part • According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

Sterilization and disinfection

As recommended by manufacturer

Mode of Operation

Continuous

v

Table of contents

Table of Contents Chapter 1 General Introduction 1.1 About the Guide ..........................................................................................................................1-2 1.1.1 Brief Introduction ...............................................................................................................1-2 1.2 Product Information ....................................................................................................................1-2 1.2.1 General

............................................................................................................................1-2

1.2.2 Main Components...............................................................................................................1-3 1.2.3 Intended Use ....................................................................................................................1-3 1.2.4 Audience ..........................................................................................................................1-4 1.2.5 Networking Capabilities .....................................................................................................1-4 1.3 Before You Begin ........................................................................................................................1-4 1.4 Monitor and Accessories Inspection............................................................................................1-5 1.5 Cleaning ......................................................................................................................................1-5 1.6 Returning the Monitor for Service ..............................................................................................1-6 1.7 Setting up the Monitor.................................................................................................................1-6 1.8 Before Powering On....................................................................................................................1-7 1.9 Setting Demo Mode.....................................................................................................................1-8 1.10 Setting the Network...................................................................................................................1-9 1.11 Updating the software..............................................................................................................1-13 1.11.1 New software.................................................................................................................1-13 1.11.2 Uport 1150 Adapter (Software Update tool)..................................................................1-13 1.11.3 Installing Uport 1150 Adapter .......................................................................................1-14 1.11.3 Creating a Hyper Terminal and connecting the monitor and PC ...................................1-16 1.11.4 Updating the Program File ............................................................................................1-19 1.11.5 Updating the Data File ..................................................................................................1-21 1.11.6 Updating the Language Resource File...........................................................................1-23 1.11.7 Language Setting...........................................................................................................1-25 1.12 Mounting Abilities...................................................................................................................1-26

Chapter 2 Maintenance 2.1 Testing and Inspecting Guidelines...............................................................................................2-2 2.1.1 Recommended Frequency ..................................................................................................2-3 2.1.2 Required Equipment...........................................................................................................2-3 2.1.3 Recording the Tests ............................................................................................................2-4 2.2 Planning Maintenance .................................................................................................................2-4 2.3 Performing Visual Inspection ......................................................................................................2-4 2.4 Cleaning and Disinfecting ...........................................................................................................2-5 2.4.1 General Guidelines .............................................................................................................2-5 TOC-1

Table of contents 2.4.2 Disinfecting Guidelines ......................................................................................................2-6 2.4.3 Cleaning the monitor ..........................................................................................................2-6 2.4.4 Cleaning the Cables............................................................................................................2-6 2.4.5 Cleaning the Accessories....................................................................................................2-7 2.4.6 Cleaning the Recorder ........................................................................................................2-9 2.5 Doing Performance Verification..................................................................................................2-9 2.5.1 Manufacturer’s Responsibility ...........................................................................................2-9 2.5.2 Performing Power Supply and Battery Test .......................................................................2-9 2.5.3 Performing ECG Test .......................................................................................................2-10 2.5.4 Performing Respiration Test (UT6000A only) ..................................................................2-10 2.5.5 Performing Temperature Test (UT6000A only)................................................................. 2-11 2.5.6 Performing Pulse SpO2 Test ............................................................................................. 2-11 2.5.7 Performing NIBP Test ...................................................................................................... 2-11 2.5.8 Performing NIBP Calibration ...........................................................................................2-14 2.5.9 Performing Speaker Test ..................................................................................................2-14 2.5.10 Performing Networking Test ..........................................................................................2-14 2.6 Performing Electrical Safety Test..............................................................................................2-15

Chapter 3 Troubleshooting 3.1 Power Problems...........................................................................................................................3-2 3.2 Display Problems ........................................................................................................................3-5 3.3 NIBP Problems............................................................................................................................3-6 3.4 Alarm Problems...........................................................................................................................3-7 3.5 SpO2 Problems ............................................................................................................................3-7 3.6 ECG Problems.............................................................................................................................3-8 3.7 Respiration Problems (UT6000A only)........................................................................................3-8 3.8 Temperature Problems (UT6000A only) ......................................................................................3-9 3.9 Recorder Problems (UT6000A only). ..........................................................................................3-9 3.10 Performance Verification.........................................................................................................3-10

Chapter 4 Theory of Operation 4.1 System Configuration..................................................................................................................4-2 4.2 Theory of Operation ....................................................................................................................4-3 4.2.1 System overview ................................................................................................................4-3 4.2.2 Block Diagram Components ..............................................................................................4-3 4.2.3 Main Board Assembly ........................................................................................................4-4 4.2.4 I/O Module ........................................................................................................................4-4 4.2.5 Display Assembly...............................................................................................................4-4 4.2.6 Speaker ............................................................................................................................4-4 4.2.7 Keys and Navigation Wheel ...............................................................................................4-5 TOC-2

Table of contents 4.2.8 AC/DC Power Module .......................................................................................................4-5 4.2.9 Recorder (UT6000A only) ..................................................................................................4-5 4.2.10 Processing the NIBP.........................................................................................................4-6 4.2.11 Processing the SpO2..........................................................................................................4-6 4.2.12 Processing the ECG..........................................................................................................4-7 4.2.12 Processing the Respiration (UT6000A only).....................................................................4-7 4.2.13 Processing the Temperature (UT6000A only) ...................................................................4-7

Chapter 5 UT4000A System Disassembly 5.1 Service Tools ...............................................................................................................................5-2 5.2 Disassembly ................................................................................................................................5-2 5.3 Removing the Power Adapter......................................................................................................5-3 5.4 Removing the Battery..................................................................................................................5-4 5.5 Disassembling the Monitor .........................................................................................................5-5 5.6 Removing the SpO2 Module .......................................................................................................5-6 5.7 Removing the ECG Module ........................................................................................................5-7 5.8 Removing the Main board Assembly ..........................................................................................5-8 5.9 Removing the Connectors Panel .................................................................................................5-9 5.10 Removing the Inverter.............................................................................................................5-10 5.11 Removing the Front Case Assembly........................................................................................ 5-11 5.12 Separating the Rear Case.........................................................................................................5-12 5.13 Removing the Speaker Assembly............................................................................................5-13 5.14 Removing the Rear Case assembly .........................................................................................5-14 5.15 Removing the NIBP Module ...................................................................................................5-15 5.16 Removing the I/O Module Assembly ......................................................................................5-16 5.17 Removing the Battery Connect Board/DC Connector.............................................................5-17

Chapter 6 UT6000A System Disassembly 6.1 Service Tools ...............................................................................................................................6-2 6.2 Disassembly ................................................................................................................................6-2 6.3 Removing the Battery..................................................................................................................6-3 6.4 Removing Power Fuses ...............................................................................................................6-4 6.5 Removing the Recorder...............................................................................................................6-5 6.6 Removing the Rear Case .............................................................................................................6-6 6.7 Removing the Connectors Panel .................................................................................................6-8 6.8 Disassembling the Main Frame ...................................................................................................6-9 6.9 Removing the Ports Frame ........................................................................................................6-10 6.10 Removing the Speaker.............................................................................................................6-12 6.11 Removing the I/O module assembly........................................................................................6-13 6.12 Disassembling the AC power assembly...................................................................................6-14 TOC-3

Table of contents 6.13 Removing the ECG Module ....................................................................................................6-15 6.14 Removing the NIBP Module ...................................................................................................6-16 6.15 Removing the AC/DC Power Module .....................................................................................6-17 6.16 Removing the Battery Connect Board.....................................................................................6-18 6.17 Removing the Inverter.............................................................................................................6-19 6.18 Removing the SpO2 module ....................................................................................................6-20 6.19 Removing the Main board Assembly ......................................................................................6-21 6.20 Removing the Front Case Assembly .......................................................................................6-22

Appendix A Electromagnetic Compatibility A.1 Instructions for use.............................................................................................................A-2 A.2 Guidance and Manufacturer's EMC Declaration................................................................A-3 A.2.1 Electromagnetic Emissions for all Equipment and Systems ....................................A-3 A.2.2 Electromagnetic Immunity for all Equipment and Systems.....................................A-3 A.2.3 Electromagnetic Immunity for Equipment and Systems not Life-Supporting....... A-5 A.2.4 Recommended Separation Distances .......................................................................A-6

TOC-4

General Introduction

Chapter 1 General Introduction

1-1

General Introduction This chapter briefly introduces the monitor and related product support information.

1.1 About the Guide 1.1.1 Brief Introduction This guide gives a brief introduction on maintenance of the UT4000A/UT6000A patient monitors, which is to be used by professionals responsible for servicing and maintaining the patient monitors. This document and the information contained in it is proprietary and confidential information of Goldway and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Goldway.

1.2 Product Information 1.2.1

General UT4000A/UT6000A Patient Monitors are for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Figure 1-1 UT4000A/UT6000A Overview Major features include: •

Battery operation for portability

•

7″ color TFT

•

Big number for optimal visibility

•

Two mounting abilities, including roll stand and wall mount

The monitor collects the physiological signals of ECG, RESP, TEMP, NIBP, SpO2 and converts the above into digital data which is analyzed and displayed. You may not have all of these functions, depending on the monitor configuration purchased. 1-2


1.2.2

Main Components The monitor can contain the following components: • Main unit • ECG • RESP • NIBP • SpO2 • TEMP • Recorder

The following table lists the models, including standard and optional features in each model. In the table, a solid circle indicates a standard feature and a hollow circle, an optional feature. Table 1-1 UT4000A/UT6000A Patient Monitors Configurations

Feature

UT4000A

UT6000A

●

●

ECG ST

None

●

TEMP1, TEMP2

None

●

RESP

None

●

NIBP

●

●

SpO2

●

●

None

○

7 inches

7 inches

Number of batteries

1

1

Ethernet RJ45 port

○

○

ECG1 (3,5 Leads)

Recorder Display Screen

1

1.2.3

The UT4000A has one ECG channel. The UT6000A has two ECG channels.

Intended Use For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations and for connectivity to clinical networks.

1-3


1.2.4

Audience This guide is for biomedical engineers or technicians responsible for troubleshooting, repair and maintenance of Goldway patient monitors.

1.2.5

Networking Capabilities You can use the UT4000A/UT6000A Patient Monitors along with other Goldway equipment to create a central monitoring system that allows remote monitoring. The monitor communicates with the UT4800 Central Monitoring System via an RJ45 port (optional) on the back of the monitor.

1.3 Before You Begin Before you start using the monitor: 1. Unpack the equipment and make sure that you have the following: – 1 patient monitor – Instructions for Use – Service Guide CD – AC power cord (country-specific) – Set of accessories – 1 External Power Adapter (UT4000A only) If anything from the packing list is missing, immediately contact Goldway or a Goldway agent.

2. Keep the packaging for future transport or storage. If it is damaged, immediately contact the courier company.

3. Examine the monitor for cleanliness and general physical condition. Make sure that the: – Housing is not cracked or broken. – Power plug and cord are in good condition and plug prongs are not bent. – External cables and accessories are in good condition and that the insulation is intact. Caution

If the equipment or packaging show signs of damage, do not use the equipment.

1-4


1.4 Monitor and Accessories Inspection 1. Before turning on the power, check the monitor and accessories to make sure there is no damage and the extension cables are correctly connected to the fittings. 2. Plug one end of the power cord into an AC power supply with a protective grounding wire. Plug the other end into the power connector on the monitor. If the monitor is powered by batteries, make sure enough power remains. 3. Power on the monitor and enter the main screen after the start-up screen. 4. Ensure that the patient cable and sensors are correctly connected. 5. Ensure that all settings like patient type, alarm limits, and so on, are correct. 6. Test the measurements and verify that the monitor is working correctly.

Warning

Never attempt to open the monitor case. Only qualified personnel should service the monitor. Observe only the instructions in this guide to install and use the monitor.

Caution

To maintain normal operation of the monitor, develop a good maintenance plan for periodic cleaning, maintenance and service. For more information, see Chapter 2 Maintenance.

1.5 Cleaning Caution

Do not immerse the monitor or its accessories in liquid or clean it with caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories. To clean the monitor: 1. Dampen a cloth with a commercial, nonabrasive cleaner, and wipe the exterior surfaces lightly. 2. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the monitor. 3. For cables, sensors, and cuffs, follow the cleaning instructions in Cleaning and Disinfecting on Page 2-5. For more detailed information, see Chapter 2 Maintenance.

1-5


1.6 Returning the Monitor for Service If it is necessary to return the monitor for service, call the Goldway Service Department. Have all equipment serial numbers available before calling.

Before returning any equipment to Goldway, decontaminate it first. To pack the monitor for return, disconnect all cables. It is not necessary to return any sensor, temperature probe, NIBP tubing and cuff, or power cord. If possible, use the original packaging materials.

Ensure that the monitor transports in the environment within the following specifications: Table 1-2 Environmental Specifications Parameter Temperature - working Temperature - storage and transportation Relative humidity - operating Relative humidity - storage and transportation Barometric pressure - working Barometric pressure - storage and transportation

Specification 10°C – 40°C (50°F – 104°F) -20°C – 55°C (-4°F – 131°F) ≤ 80% ≤ 95% 70 kPa – 106 kPa 50 kPa – 106 kPa

1.7 Setting up the Monitor Place and use the monitor in any appropriate location that conforms to the environmental specifications in the UT4000A/UT6000A Patient Monitors Instructions for Use.

Locate the monitor in an area that: • Is convenient for observation and operation • Is free from movement, dust, corrosive or explosive gases • Has a five centimeter space around to ensure good ventilation and smooth heat dissipation Caution

Warning

Only install the monitor as outlined in this Service Guide. Never block the monitor’s air vent during operation. Always keep the monitor free from condensation and temperature changes when transporting it from one location to another. Never place the monitor in a location where the patient might inadvertently knock it off the bed.

1-6


1.8 Before Powering On Warning

Never disassemble the monitor before disconnecting the power cable from the AC power source or from the AC power connector on the side panel of the monitor. After connecting the monitor to an AC power, it can be put into operation. Before turning on the monitor: 1. Ensure that the AC power source complies with any AC power regulations. Note — Only connect the monitor to a power outlet with correct protective grounding. If no grounded power is available, only use the monitor with internal batteries. 2. Connect the monitor to a single-phase AC power source. Note — For UT4000A monitors, connect the monitor to an AC power with adapter through the AC cord. 3. Check that the power led on the front panel is yellow. This means that the AC power is correctly connected.

Warning

Personnel connecting additional devices to input and output connectors are responsible for system compliance with the IEC 60601-1-1 standard. If you cannot determine the safety of the monitor when combining it with another medical device, contact Goldway to ensure that the combined devices are safe and will not cause electric shock or other hazards. When safety (for example an electrical shock caused by the sum of current leakage) cannot be determined from the specific combination of the monitor and other medical devices, contact the service representative, to ensure necessary safety.

1-7


1.9 Setting Demo Mode Demo mode lets you demonstrate the monitor without monitoring parameters. To set the Demo mode: 1. Rotate the navigation wheel to

, and press the wheel to enter System

Menu. 2. Rotate the wheel to the Sys. Maint., and press the wheel. A password window appears. Note — This Password is 8727, that is only is availability for selecting Demo. 3. Enter the password, and press OK to show the Sys. Maint. menu. 4. Rotate the wheel to Demo, and press the wheel to enter Demo menu. 5. Rotate the wheel to ON or OFF and press to confirm the selection 6. Rotate the wheel to OK and press to exit.

1-8


1.10 Setting the Network

Note — This setting is only used on UT4000A (Version 6.* and higher) and UT6000A

(Version 6.* and higher) with network module. Default IP address of the monitor network module is 192.168.0.250.

Before setting the network features, connect the monitor to the central monitoring system via a network cable and a network switch. You can set the network features of the monitor either through the central monitoring system PC or via another networked PC connected to the LAN. Then, power on the monitor.

1. From the Central Monitoring System, Open Internet Protocol (TCP/IP) Properties, and mark down the IP address and Subnet mask of central monitoring system, For example, the central monitoring system IP address is 192.168.2.98, Subnet mask is 255.255.255.0. Caution

If you use another networked PC, also mark down its IP address and Subnet mask in order to restore itafter setting the monitor network features. 2. Set the PC and monitor to be in the same network. Open the Internet Protocol (TCP/IP) Properties of the central monitoring system PC (or another PC), set PC IP address as 192.168.0.* (Range of * is 1-100) and ensure that the IP address 192.168.0.* is not used in other device on the LAN. Set the Subnet mask as the same as the central monitoring system. For example (Figure 1-2) set PC IP address to 192.168.0.88, and set the Subnet mask to 255.255.255.0.

Figure 1-2 TCP/IP Setting 1-9

General Introduction 3. Open a browser and type in the address bar: 192.168.0.250. Enter to link NePort-R module. Both the default user name and the password are admin.

Figure 1-3 Linking Interface 4. Click OK and entered NePort Web Console interface.

Figure 1-4 NePort Web Console interface

1-10

General Introduction 5. Click Network, enter Network Settings interface. Set the Subnet as same as central monitoring system. If the Subnet is 255.255.255.0, set the IP address to 192.168.*.** (192.168.* must be the same to the front 3 segments IP address of the central monitoring system. Range of ** is 1-249 and except the address has used in this LAN). Keep other parameters as the original. After that, click OK. For example, change the IP address here to 192.168.2.50 and Subnet mask to 255.255.255.0. (Figure 1-5)

Caution

If the Subnet is not 255.255.255.0, contact Goldway to confirm the network settings.

Set the IP address is 192.168.0.*.

Set the Subnet as same as central monitoring system.

Figure 1-5 Networking Setting

1-11

General Introduction 6. Click Serial1 Settings, enter the serial settings. Make sure that parameters are set as the same as Figure 1-6. Other parameters remain the original. Click OK after setting.

Figure1-6 Serial1 Setting

7. Click connection1, and enter the connection settings. Set the parameters according to Figure 1-7. Other parameters remain the original. Set the Remost Host the actual Central monitoring system IP address. Click OK to exit. For example, change the Remost Host here to 192.168.2.98. (Figure 1-7.)

Figure 1-7 Connection1 Setting

8. Click Apply / Reset. 9. Click the Submit in Apply / Reset Interface to save the settings. 1-12

General Introduction 10. Restore the network setting of central monitoring system PC (or another PC) 11. Restart the monitor.

1.11 Updating the software

Before you perform a software update, you need the following equipment and material: y

One PC with CD-ROM

y

One Network Cable

y

New Software

y

One Uport 1150 Adapter (Software Update tool)

Note —This process is only used on UT4000A (Version 6.* and higher) and UT6000A (Version 6.* and higher).

1.11.1 New software Before you update the software, check that the new software includes following the contents as Table 1-3: Note — The new software from Goldway with Goldway FCO and your requirement when you want update the software of old version monitors.

Table 1-3 The software File Name 6A_Flash_V*.**.bin1 6A_Eeprom_V*.**.bin1 6A_Language_V*.**.bin1

Description UT4000A/UT6000A M128 program file UT4000A/UT6000A M128 data file UT4000A/UT6000A Language resource file

1. V*.** is the actual latest version number

1.11.2 Uport 1150 Adapter (Software Update tool) 1.

You must purchase this tool from Goldway, p/n is 85201512000.

It includes: y

IFU for Uport 1150 Adapter

y

Connect cable DB9-RS422 200mm

y

USB-RS232/RS422 Uport1150 Adapter

y

Uport 1150 Adapter installation CD

1-13


2.

Assemble the USB-RS232/RS422 Uport1150 Adapter and Connect cable DB9-RS422 200mm as described in Table 1-4 and shown in Figure 1-8.

Table 1-4 Uport1150 Adapter bond holes connection Line Color of Connect cable DB9-RS422 200mm 1 2 3 4 5

Yellow Green Black Blue (None)

Bond hole names of USB-RS232/RS422 Uport1150 Adapter T+ TR+(D+) R- (D- ) GND

Figure 1-8 Uport1150 Adapter bond holes connection

1.11.3 Installing Uport 1150 Adapter 1.

Insert Uport 1150 Adapter installation CD into the PC and open CD. Install the driver software under the following path:

*:\UPort 1150_1150I\Software\Windows XP_2003_Vista\x86\driv_win_uport1p_v1.5_build_07122513.exe

Note — Select the corresponding folder (bolded in the above path) according to your actual windows system.

1-14

General Introduction 2.

Plug USB-RS232/RS422 Uport1150 Adapter into an USB port of the PC. The system displays a pop-up window alerting that new hardware is found. Select automatic installation and complete the driver installation.

3.

Restart the PC.

4.

Click following options step by step to find Device Manager as shown in Figure 1-9: Start →Control Panel → System →Hardware →Device Manager.

Figure 1-9 Device Manager

5.

Double click Uport 1150 and click Ports Configurations (Figure 1-10).

Figure 1-10 Ports Configurations

1-15


Double click the item inside (Circle in Figure 1-10). The Port 1 window appears (Figure 1-11).

Figure 1-11 Port1

7.

Set the Interface to RS-422 (Circle in Figure 1-11) and keep others the default settings.

8.

Make down the Port Number name ( Rectangle in Figure 1-11). For example, there is COM3 (current).

9.

Click OK and complete the configuration.

1.11.3 Creating a Hyper Terminal and connecting the monitor and PC 1.

Connect the monitor and computer with Uport 1150 Adapter(Figure 1-12)

Figure 1-12 Connect the monitor and computer

1-16


Connect the monitor to AC power.

3.

Click start at the lower left quarter of the computer screen.

4.

Click the following options step by step to create a Windows HyperTerminal.

5.

All Programs → Accessories → Communications → Hyper Terminal → New Windows Hyper Terminal. The Connection Description pop up is displayed (Figure 1-13).

6.

Enter a name and choose an icon for the connection and click ok. For example, enter COM3 115200 here.

Figure 1-13 Connection Description

7.

Set the Connect using area in the Connect to window according to the Port number of Uport1150. (Figure 1-14). For example, set it to COM3. (See Figure 1-11 in Page 1-16)

Figure 1-14 Connect to

1-17


Setting COM Properties as shown following Figure 1-15: y

Bits per second: 115200

y

Data bits: 8

y

Parity: None

y

Stop bit: 1

y

Flow control: None

Figure 1-15 COM Properties

9.

After the Hyper Terminal window appears, hold down the CTRL + C and power on the monitor. Figure 1-16 describes the right messages on the terminal window.

Note — If the messages are not intact as shown, press Enter to refresh.

Figure 1-16 Hyper Terminal windows-1

1-18


1.11.4 Updating the Program File 1.

Type number zero (0) and press Enter. Wait until the letters C appear as shown in Figure 1-17.


2.

Click Transfer in the Menu of Hyper Terminal window.

3.

Click Send File to open the dialogue window appears as Figure 1-18.

Figure 1-18 Send File-1

4.

Click Browse… to find File 6A_Flash_V*.**. Bin and set Protocol to Xmodem.

5.

Press Send to complete it.

1-19


Wait until the sending is completed. The progress bar and data are displayed here. (circle in Figure 1-19)

Figure 1-19 Xmodem file send… window-1 Note — If error message appears or the sending is interrupted, retry until the file is send successfully. 7.

After the sending completed. There is a word done in Hyper Terminal window. (Circle in Figure 1-20)


1-20


1.11.5 Updating the Data File 1.

Type the number One (1) and press Enter. Wait until the letters C appear as shown in Figure 1-21


2.

Click Transfer in the Menu of Hyper Terminal window:

3.

Click Send File to open the dialogue window appears as Figure 1-22.


4.

Click Browse… to find File 6A_ Eeprom_V*.**. Bin and set Protocol to Xmodem.

5.


1-21


Wait until the sending is completed (Figure 1-23). The progress bar and data are displayed here. (Circle in Figure 1-23)

Figure 1-23 Xmodem file send… window-2

7.

After the sending is completed, the word done appears in the Hyper Terminal window. (Circle in Figure 1-24)


1-22


1.11.6 Updating the Language Resource File 1.

Type the number Two (2) and press Enter. Wait until the letters C appear as shown in Figure 1-25


2.

Click Transfer in the Menu of Hyper Terminal window:

3.

Click Send File to open the dialogue window in Figure 1-26.


4.

Click Browse… to find File 6A_Language_V*.**. Bin and set Protocol to Xmodem.

5.


1-23


Wait until the sending is completed. The progress bar and data are displayed here. (circle in Figure 1-27)

Figure 1-27 Xmodem file send… window-3

7.

After the sending is completed, the word done appears in the Hyper Terminal window. (Dark red circle in Figure 1-28)


1-24


1.11.7 Language Setting 1.

Type the number Three (3) and press Enter. Wait until the language type list appears (Figure 1-29). Remember the id of the language which you want to install (rectangle of Figure 1-29).

Figure 1-29 Hyper Terminal windows-8 2.

Type the number Four (4) and press Enter to enter the load language progress. (Figure 1-30)

3.

Type the id number (the id number of language which you want to install) and press enter. The information load language success means the software updating is completed. For example, when setting the UT4000A for English enter 2. (Circle in Figure 1-30)

Figure 1-30 Hyper Terminal windows-9 1-25


Power off the monitor.

5.

Disconnect the Uport 1150 adapter from the monitor and PC.

6.

Repower the monitor and check the software version.

1.12 Mounting Abilities The UT4000A/UT6000A Patient Monitors have two mounting options, including a roll stand and a wall mount. Before mounting the monitor, the patch board must be attached first as shown below To mount the Patch Board to the UT4000A: 1. Screw up and mount the Adapter Plate on the bottom of monitor.

Figure 1-31 Adapter Plate of UT4000A

2. Attach the Mounting adapter that comes with the mounting solution.

Figure 1-32 Mounting adapter of UT4000A

For information on mounting the monitor on the roll stand or the wall mount, see Goldway Roll Stand Installation Guide and Goldway Wall Mount Installation Guide.

1-26

General Introduction To mount the patch board to UT6000A: 1. Screw up and mount the Adapter Plate on the bottom of monitor.

Figure 1-33 Adapter Plate of UT6000A

2. Attach the Mounting Adapter that comes with the mounting solution.

. Figure 1-34 Mounting adapter of UT6000A

For information on mounting the monitor on the roll stand or the wall mount, see Goldway Roll Stand Installation Guide and Goldway Wall Mount Installation Guide.

1-27

Maintenance

Chapter 2 Maintenance

2-1

Maintenance

This chapter describes how to inspect and maintain the UT4000A/UT6000A Patient Monitors.

2.1 Testing and Inspecting Guidelines Table 2-1 lists the tests that Goldway requires to complete after performing monitor installations, repairs, or software upgrades.

Table 2-1 Testing and Inspecting Guidelines

After …

Complete …

Installing or software updating

Visual inspection Power supply and battery test

Opening the monitor

Speaker Test Power Supply and Battery Test NIBP Test All safety tests

Replacing any internal parts

Power Supply and Battery Test

(except the SpO2 and ECG

NIBP Test

module)

Temperature Test Speaker Test All safety tests

Replacing the ECG module

Power Supply and Battery Test ECG test Speaker Test Respiration Test All safety tests

Replacing the SpO2 module

Power Supply and Battery Test Pulse SpO2 Test All safety tests

2-2

Maintenance

2.1.1 Recommended Frequency Perform the test procedures at the recommended frequency outlined in Table 2-2. Caution

The frequency specified in Table 2-2 do not supersede local requirements. Always perform both locally required testing and the testing outlined in the table.

Table 2-2 Recommended Frequency Tests

Frequency

Preventive Maintenance NIBP Calibration

Once a year, or more often if specified by local laws.

Performance Once a year, or if you suspect the measurement is incorrect.

• NIBP Accuracy Test • Pulse SpO2 Test

Safety (In accordance with IEC 60601-1) Once every two years, and after repairs where the unit has been opened (front and back separated) or the monitor has been damaged by impact.

• System Enclosure Leakage Current • Ground Integrity • Patient Leakage Current

2.1.2 Required Equipment The following Table 2-3 lists test required equipment needed, in order to perform the tests. Many of the tests use the standard accessories shipped with the monitor.

Table 2-3 Required Test Equipment Performing …

You Need…

Visual inspection

None

Power Supply and Battery Test

None

Speaker Test

None

Pulse SpO2 Test

• Adult SpO2 sensor

ECG/Respiration Performance Test NIBP Test

• Patient simulator • ECG trunk cable and lead set •Reference manometer (includes hand pump and valve), accuracy 0.2% of reading •Expansion chamber (volume 500 ml ±10%) •Piece of appropriate tubing

NIBP Calibration

None

Temperature Test

•Patient simulator (with 0.1ºCor 0.2ºF )

Safety Tests

•Electrical Safety Tester 2-3

Maintenance

2.1.3 Recording the Tests Authorized Goldway personnel report test results back to Goldway to add to the product development database. Hospital personnel, however, do not need to report results. Table 2-4 describes what to record on the service record after you complete the tests in this chapter. Table 2-4 Testing Record

Tests

Recording…

Visual inspection

VI:P or V:F

Power Supply and Battery

PB:P or PO:F

Test NIBP Test

NT:P/X1/X2/X3 or NT:F/X1/X2/X3

Safety Tests

S(1):P/X1/X2 or S(1):F/X1/X2 S(2): P/X1 or S(2): F/X1 S(3): P/X1 or S(3): F/X1

Note: P = pass, F = fail, X = measured value as defined in tests in this chapter

2.2 Planning Maintenance To maintain proper performance of the monitor, a good maintenance plan must be made. We recommend the following: y

Visual Inspection

y

Cleaning and Disinfecting

y

Performance Verification

y

Leakage Current Test

2.3 Performing Visual Inspection Before use, the operator should inspect the exterior appearance of the equipment. Service personnel should inspect the exterior appearance of the equipment before maintenance. 1.

Carefully inspect the exterior of the monitor, display and control parts to see if 2-4

Maintenance there is any apparent physical damage. If yes, do not use the monitor. Contact the authorized service personnel and report the damage until problems are settled before connecting the monitor to patients. 2.

Inspect all cables, connecting wires and external connectors. Do not use for any show signs of damage. Contact authorized service personnel and reports the damage until problems are settled before connecting the monitor to patients.

3.

Check and make sure the safety marks on the equipment are legible.

2.4 Cleaning and Disinfecting This chapter gives general guidelines on the cleaning and care of your monitor and accessories. Use only the approved cleaning methods and agents listed in this chapter. The warranty does not cover damage caused by using unapproved substances. Cleaning methods described in this chapter have been tested by Goldway. Other methods and cleaning agents may contaminate or damage the monitor. In addition, qualified professionals should perform calibration and maintenance of the monitor periodically.

2.4.1 General Guidelines Keep the monitor, cables and accessories free of dust and dirt. After cleaning and disinfecting, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Goldway, decontaminate it first.

Follow the following general precautions: • Always dilute cleaning agents according to the instructions in this chapter or use the lowest possible concentration. • Never let liquid enter the monitor case. • Never immerse any part of the equipment in liquid or allow any liquid to enter electrical contacts. • Never use abrasive material (such as steel wool or silver polish). • Never use bleach, strong solvents, or acetone on any part of the monitor • Never autoclave, steam sterilize, or ultrasonically clean the monitor or cables • Never use alcohol on the patient cables. Alcohol can cause the plastic to become brittle and fail prematurely.

2-5

Maintenance

Caution

If you see any signs of deterioration or damage on any accessory, do not use it, and replace it with a new one. Use the equipment according to instructions accompanied with the sensors. The manufacturer information might be more current. If you spill liquid on the exterior of the monitor, use a clean cloth to dry the monitor. If you believe the liquid may be inside the monitor, power off the monitor and contact your service representative.

2.4.2 Disinfecting Guidelines To avoid long-term damage to cables, do not disinfect a cable unless directed by the hospital. Always power off the monitor and clean it before performing any disinfection.

Do not use strong solvents for disinfection. Always dilute cleaning agents according to the manufacturer’s instructions or use the lowest possible concentration. Disinfect the equipment with a cloth moistened with these materials. – 70% ethanol, 70% isopropyl alcohol – Acetaldehyde: Cidex

Caution

When disinfecting any accessories, follow the manufacturer’s instructions; otherwise, use the disinfection agents listed in this chapter.

2.4.3 Cleaning the monitor Before you clean the monitor, power off the patient monitor and unplug the power cord. 1. Clean the monitor casing and screen with a cloth moistened with liquid detergent or one of the following cleaning agents: – Mild soap – Alconox dish washing detergent – Ammonia, 3% and window detergent – Ethanol 70%, 70% isopropyl alcohol, window detergent. 2. Air dry the cleaned parts or use a cloth.

2.4.4 Cleaning the Cables Keep the cables free from dust: 1. Use a lint-free cloth dampened with warm water (maximum 40℃/104℉) and soap or a diluted non-caustic detergent. 2. Dry the equipment with a soft cloth. 2-6

Maintenance

2.4.5 Cleaning the Accessories When possible, clean the accessories according to the manufacturer’s instructions. Use the general guidelines in this chapter if you do not have specific product cleaning instructions. 2.4.5.1 Cleaning the SpO2 Accessories SpO2 reusable sensors should be cleaned and disinfected, but never sterilized.

Warning

Use only the validated cleaning agents and disinfectants listed below. Using other agents may damage the sensor or its connecting wires, shorten product lifetime, or cause safety hazards. Select disinfectants carefully as some have very similar names but very different compositions. Never immerse the sensor connector in any of the cleaning solutions, disinfectants, or other liquids. The sensor and cable housing may be immersed, however. Never soak sensors in disinfectants longer than specified by the disinfectant manufacturer. Never sterilize or autoclave the sensors.

Validated Cleaning Agents • Mild detergent • Salt solution (1%)

Validated Disinfectants • Metricide® 28 • Cidex® Formula 7 • Kohrsolin® (2%) • Metricide® Plus 30 • Cidex® OPA • Mucapur®-CD (1%) • Terralin® Liquid • Cidex® Plus • Isopropanol (70%) or Isopropanol Wipes (70%) • Incidin® Liquid • Omnicide® 28 To clean and disinfect the sensor: 1. Clean the sensor according to the instructions supplied with the cleaning agent. 2. Disinfect the sensor according to the instructions supplied with the disinfectant. 3. Wipe the exterior surfaces lightly. Do not allow liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the 2-7

Maintenance

monitor. 4. Dispose of any sensor showing signs of deterioration or damage. 2.4.5.2 Cleaning the NIBP Cuffs To clean the cuff: 1. Remove the bag from inside the cuff. 2. Clean the cuff in detergent (mild soap water) and air dry it. 3. Check the cuff and tube. To sterilize the cuff to avoid cross-infection: 4. Disinfect the cuff in an autoclave or immerse it into one of the following detergents: 70% isopropanol or 70% ethanol To put the rubber inflation bag back into the cuff: 1. Roll the bag from both ends in the direction of the tube. 2. Insert the rolled bag from the tube side into the opening on the short side of the cuff. 3. Push the tube through to the other side of the cuff. 4. Hold the tube together with the cuff and shake the whole cuff until it reaches the bag.

Note — Never dry-clean the cuff.

2.4.5.3 Cleaning the Temperature Accessories Clean the temperature sensor after each use. To clean the temperature sensor: 1. Hold the probe with one hand and clean the sensor from the top with a wet lint- free cloth dampened with isopropanol. 2. In addition, regularly disinfect the sensor with ethylene oxide. 3. Use a dry cloth to clean the surface of the temperature sensor. 4. Check the temperature sensor and do not use it if you see any signs of damage or deterioration.

Caution

Never heat the sensor to over 100℃ (212℉). Only heat it to 80℃ (176℉) - 100℃ (212℉) for a short time.

2-8

Maintenance

2.4.6 Cleaning the Recorder After extended use, deposits of paper debris may collect on the print head making recordings uneven and faint, shortening the life of the print head and the roll shaft.

To clean the print head: 1. Apply an anti-static agent to the recorder door, and open the door. 2. Remove the paper roll from the recorder. 3. Thread a cloth cleaning strip around the roller until the strip comes out of the top of the roller. 4. Pull the strip through the roller. 5. Clean the roller housing gently with a soft cloth. 6. Soak a cotton swab in alcohol and gently wipe the surface of the thermal printer head. 7. Reload the paper roller after the alcohol is dried and close the recorder door. Caution

Always apply an anti-static agent to protect against ESD damage.

2.5 Performance Verification When the monitor is received, a qualified person should inspect the monitor thoroughly and verify its performance. Service personnel inspect the monitor thoroughly and verify performance every 12 months or whenever necessary.

2.5.1 Manufacturer’s Responsibility If the maintenance plan is not observed, which leads to inaccurate measurement of the monitor or potential hazards to operators or patients, unless otherwise agreed by both parties, manufacturer shall not undertake any responsibilities. All responsibilities shall be undertaken by the user of the monitor.

2.5.2 Performing Power Supply and Battery Test 1.

Connect the monitor to an AC power adapter and connect the AC cord to the wall outlet (UT4000A). Connect the power cord between the wall outlet and monitor power connector (UT6000A).

2.

Power up the monitor.

2-9

Maintenance

3.

Check if the power led is on and in either color of the following: Green: The monitor is powered on and in normal working status. Yellow: The monitor is connected to AC power but not turned on. It is under internal battery charging status.

4.

Press the On/Off key of the monitor to turn on the monitor and unplug the power cable. Inspect if the power LED is green and if a battery icon displaying in the status box on the screen, showing that the monitor is powered by batteries.

2.5.3 Performing ECG Test To set the ECG Simulator: 1.

Set the HR to 80bpm and ECG gain to 1mV.

To test the ECG: 1.

Connect one end of the ECG cable to the ECG connector of the monitor and the other end to the simulator.

2.

Confirm that the patient simulator has been properly connected to the monitor.

3.

Confirm and make sure the ECG lead II is displayed on the ECG channel, without noise and the heart rate displays 80±2bpm. When the R wave appears you should hear a beep.

4.

Confirm every ECG lead and make sure there is an ECG waveform and no noise interference.

5.

Adjusting the ECG gain to 2mV, and confirm the change in the ECG waveform.

6.

Unplug the RA from the simulator, and confirm that a lead off message pops-up.

7.

Reconnect RA lead.

8.

Set the 1mV calibration in the ECG menu, and confirm that a 1mV calibration square wave is overlapped on the ECG waveform.

9.

The ECG test is complete.

2.5.4 Performing Respiration Test (UT6000A only) 1.

Connect ECG cable to the monitor ECG connector.

2.

Configure the ECG Simulator and set the respiration baseline resistance to 500 Ohm, Respiration Delta R to 0.5 Ohm, Respiration lead to I or II and Respiration rate to 30bpm.

3.

Set the respiration lead to RA-LA or LL-RL and set the respiration waveform channel for display 2-10

Maintenance 4.

Confirm that the respiration rate displays 30±2rpm and the waveform channel displays the respiration waveform.

5.

Change monitor respiration lead and confirm that the parameter and waveform remain the same.

6.

Unplug the ECG cable and the respiration test is completed.

2.5.5 Performing Temperature Test (UT6000A only) 1. Connect the patient simulator to the temperature connector on the monitor 2. Configure the patient simulator to 40℃ (100℉). 3. Wait for the monitor to display the static temperature value. The value should be 40℃ ± 0.2℃ (100℉±0.4℉).

2.5.6 Performing Pulse SpO2 Test 1. Connect an adult SpO2 sensor to the SpO2 connector on the monitor. Make sure that the LED transmitter is lit. 2. Insert your finger into the sensor (assuming that you are a healthy adult). 3. Verify that the SpO2 value displayed on the monitor is between 95% and 100%. If not, retest again with a patient simulator.

2.5.7 Performing NIBP Test An authorized service representative should perform pressure tests and parameter calibration every 12 months or whenever you suspect incorrect blood pressure readings. Always check to see if the cuff or hose has a leak. Replace the cuff or hose as necessary.

If the pressure reading is compared with a precise blood pressure meter, and the difference is more than

±3mmHg, the monitor needs pressure calibration. Authorized

personnel can perform the required calibration. Before you start, see Required Equipment on Page 2-3. The following tests verify the performance of the non-invasive blood pressure measurement. y

NIBP accuracy

y

NIBP overpressure valve

y

NIBP calibration procedure (if required)

2-11

Maintenance

Testing the NIBP accuracy: 1. Connect the manometer and the pump with tubing to the NIBP connector on the UT4000A/UT6000A Patient monitor. (Figure 2-1 and Figure 2-2)

Figure 2-1 Connect the tubing and UT4000A Patient Monitor

Figure 2-2 Connect the tubing and UT6000A Patient Monitor

2. Connect the tubing to the expansion chamber (500ml cylinder). 3. Press

on the front panel of the monitor to freeze the waveform of the screen.

4. Rotate the navigation wheel to the icon

, and press the wheel to enter the

Parameter menu. 5. Rotate the wheel to NIBP and press to enter the menu. 6. Rotate the wheel to Work mode and set it to Test. 7. Squeeze the manometer pump with the air chamber to apply a pressure of 50mmHg. 2-12

Maintenance 8. Press

on the front panel of the monitor.

Note the pressure displayed in the NIBP numeric pane and record this result as X1 (see Recording the Tests on Page 2-4). It should be 50mmHg ±3mmHg. to stop the test.

9. Press the

10. Squeeze the manometer pump with the air chamber to apply a pressure of 50mmHg. 11. Press

.

Note the pressure displayed in the NIBP Numeric Pane and record the result as X2. 250mmHg ± 3mmHg is a proper result. to stop the test.

12. Press the

If the difference between the manometer and displayed values is greater than 3mmHg, calculate the difference by the following formula, and then calibrate the monitor (See Performing NIBP Calibration on Page 2-14). Vadj = [(X1 – 50) + (X2 – 250)] / 2 If the difference between the manometer and displayed values is not greater than 3mmHg, go to the Testing the Overpressure.

Testing the Overpressure: 1. Press




Parameter menu. 3. Rotate the wheel to NIBP and press to enter the menu. 4. Rotate the wheel to Work mode and set it to Test. 5. Rotate the wheel to Patient Type and set it to Adult. 6. Squeeze the manometer pump with the air chamber to apply a pressure of 290mmHg. 7. Press

and verify the valves are opened

8. Release the pressure on the manometer. 9. Rotate the wheel to Patient Type and set it to Neo. 10. Squeeze the manometer pump with the air chamber to apply a pressure of 150mmHg. 11. Verify the valves are opened 12. Release the pressure on the manometer.

2-13

Maintenance

2.5.8 Performing NIBP Calibration 1. Press




Parameter menu. 3. Rotate the wheel to NIBP and press to enter the menu. 4. Rotate the wheel to Calibration and press. 5. Rotate the wheel to select one appropriate value most close to Vadj. 6. The NIBP Calibration is completed.

2.5.9 Performing Speaker Test 1. Turn on the alarm sound and set the heart rate alarm limits. Confirm that the monitor provides an alarm sound when the heart rate is out of the alarm limits. 2. Silence the alarm sound and confirm that the monitor provides an alarm sound when heart rate is again out of the alarm limits. 3. Reset the alarm limits. Speaker test is completed.

2.5.10 Performing Networking Test After the monitor is connected to the UT 4800 Central Monitoring System, confirm that the ECG waveform and its parameters are correctly displayed on the Central Monitoring System.

2-14

Maintenance

2.6 Performing Electrical Safety Test Service personnel should inspect the monitor thoroughly every 12 months or whenever necessary. Electrical safety test inspects whether the monitor has potential hazards to patients or operators.

In order to establish a systematic maintenance plan, we recommend all safety tests and records shall be made under the following circumstances: Upon reception of the monitor, every year, and the monitor is opened for repair.

Use the following safety test procedures for verifying safe installation or service of the monitor. The setups used for these tests and the acceptable ranges of values are derived from local and international standards but may not be equivalent. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using the Metron Safety tester, perform the tests in accordance with your local regulations, for example in Europe use IEC60601-1/IEC60601-1-1. The Metron Report should print results with the names listed below, together with other data.

The monitor safety tests include: • System Enclosure Leakage • Ground integrity • Patient leakage current with mains voltage

System Enclosure Leakage

Figure 2-3 S(1) Part 1: System Enclosure Leakage Current - NC (normal condition) 2-15

Maintenance

Expected Test Results Normal condition maximum leakage current x1 ≤ 100μA. This measures leakage current of exposed metal parts of Instrument under Test (IUT) and between parts of the system within the patient environment; normal and reversed polarity using S2. Safety test according IEC 60601-1 / UL2601-1.

Figure 2-4 S(1) Part 2: System Enclosure Leakage current - Single Fault (open earth)

Expected Test Results Single Fault maximum leakage current x2 ≤ 500μA (IEC 60601-1)≤ 300μA (UL2601-1). This measures leakage current of exposed metal parts of Instrument under Test (IUT) with Protective Earth (PE) open circuit (S4 = open) and between parts of the system within the patient environment; normal and reversed polarity using S2.

Figure 2-5 S(2) Protective Earth Continuity

2-16

Maintenance

Expected Test Results With mains cable, maximum impedance x = 100 mOhms (IEC 60601-1 and UL2601-1). This measures impedance of Protective Earth (PE) terminal to all exposed metal parts of Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE). Test current 25 Amp applied for 5 to 10 seconds.

Patient Leakage Current with Mains Voltage

Figure 2-6 S(3) Patient Leakage current - Single Fault Condition (S.F.C.) mains on applied part

Expected Test Results Maximum leakage current, x = 50μA @ 250V (IEC60601-1 and UL2601-1). Measures patient leakage current from applied Part to earth caused by external main voltage on applied Part with switch S5 open and closed. Each polarity combination possible is tested using S2 and S6. This test is applicable for every measurement input.

2-17

Troubleshooting

Chapter 3 Troubleshooting

3-1

Troubleshooting

This chapter describes how to troubleshoot monitor problems.

3.1 Power Problems Symptom I can’t turn on the monitor with AC Power, but can with battery power.

Possible cause The cord is unplugged or broken. The fuse is blown. (UT6000A only) The AC power adapter has malfunctioned. (UT4000A only) The AC/DC power cable has malfunctioned.

The AC/DC power module has malfunctioned. (UT6000A only)

The front case assembly of monitor is worn.

The main board has malfunctioned.

I can turn on the monitor with AC Power, but not battery power.

The battery has run out.

The battery or connector is loose. The battery does not have a connection to the Main board module.

The main board module has malfunctioned.

I can’t get the monitor to turn on with either AC or battery power.

The LCD, cables, battery, AC/DC Power Module or main PCB has malfunction 3-2

Action Ensure that the AC power cord is plugged into an outlet. Replace the fuse. See Removing Power Fuses on page 6-4. Replace the Adapter. See Removing the Power Adapter on page 5-3. Replace the battery connect Board or DC Connector. See Removing the Battery Connect Board/DC Connector on page 5-17. (UT4000A) See Removing the Battery Connect Board on page 6-18. (UT6000A) Check output voltage on AC/DC Power Module. If you do not capture 15 V, replace the AC/DC power module. See Removing the AC/DC Power Module on page 6-17.(UT6000A) Replace the front case assembly. See Removing the Front case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Charge the battery or replace it, see Removing the Battery on page 5-4 (UT4000A) or 6-3 (UT6000A). Reseat both the battery and battery cable. Replace the battery connect Board or DC Connector. See Removing the Battery Connect Board/DC Connector on Page 5-17. (UT4000A) See Removing the Battery Connect Board on Page 6-18. (UT6000A) Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Follow the steps in the decision trees in the following power problem processing.

Troubleshooting

Prepare the following before troubleshooting: 1.

One good battery with enough charge (not fully charged) and a good fuse.

2.

Battery’s voltage is above 11V

3.

Standard tools

4.

Verify that supply mains is OK (measure by an multi-meter)

Figure 3-1 Power Problems Processing Chart

3-3

Troubleshooting

Figure 3-2 J160 Pin Definition

Table 3-1 J160 Pin Definition Pin1 GND

Pin2 GND

Pin3 (Signal)

Pin4

Pin5

(Signal)

15V

Pin6 15V

Figure 3-3 J60 Pin Definition Test Points

Table 3-2 J160 Pin Definition

GND Test Point GND

VIN Test Point AC/DC power module output 15V

3-4

VBAT Test Point Battery power output 12V

Troubleshooting

3.2 Display Problems Symptom

Possible Cause

Action

Power is on, but the monitor screen is Blank

There is a bad connection between the backlight LCD to others

Ensure that there is a proper connection between the cable, LCD, backlight and main board module. Replace the inverter. Removing the Inverter on page 5-10 (UT4000A) or 6-19 (UT6000A). Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Open the monitor and reseat the LCD signal cable. Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Ensure that all connectors to the Main board module are seated correctly. Replace the front case assembly. See Removing the Front Case Assembly on page 5-11 (UT4000A) or 6-22 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A).

There is a bad inverter.

There is a bad LCD.

The Main board module has malfunctioned.

The monitor displays random/ distorted graphics with a white background.

The LCD cable is not connected correctly. The LCD has malfunction.


The monitor does not respond to the navigation wheel or keys.

There is a bad connection to the Main board module. The monitor keypad or navigation wheel is broken.


3-5

Troubleshooting

3.3 NIBP Problems Symptom

Possible Cause

Action

The NIBP cuff does not inflate

The tube or cuff is kinked.

Straighten the tube or cuff.

There is an air leak in the air tube or cuff.

Replace the cuff and ensure that there is no air leakage in the tube. Replace the NIBP module. See Removing the NIBP Module on page 5-15 (UT4000A) or 6-16 (UT6000A). Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively. Use proper cuff size, ensure proper cuff placement. Ensure that the tube is straight and not kinked. Replace the cuff and ensure that there is no air leakage in tube. Replace the NIBP module. See Removing the NIBP Module on page 5-15 (UT4000A) or 6-16 (UT6000A).

The NIBP module has malfunctioned.

There are no NIBP readings

There have external problems.

Wrong cuff size or incorrect cuff placement. The tube is kinked or there is air leakage in the air tube or cuff.

There is an NIBP module error.

I’m getting unreliable NIBP readings


Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A).

Wrong cuff size or incorrect cuff placement. There have been some external problems.

Use proper cuff size, ensure proper cuff placement. Ensure that all external blood pressure reading requirements are met and that the patient is not moving excessively.

3-6

Troubleshooting

3.4 Alarm Problems Symptom

Possible Cause

Action

No alarm.

There is a bad connection to the speaker. The speaker has malfunction.

Ensure that the connection to speaker is correct. Replace the speaker. See Removing the Speaker Assembly on page 5-13 (UT4000A) or 6-12 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A).


3.5 SpO2 Problems Symptom

Possible Cause

Action

There are no SpO2 readings

The SpO2 sensor has malfunctioned. The SpO2 module has malfunctioned.

Replace the SpO2 sensor.


The SpO2 readings are unreliable

There has been some external problem.

3-7

Replace the SpO2 board. See Removing the SpO2 module on page 5-6 (UT4000A) or 6-20 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Ensure that all external SpO2 reading requirements are met and that the patient is not moving excessively.

Troubleshooting

3.6 ECG Problems Symptom

Possible Cause

Action

There are no ECG readings

The ECG leads are off.

Ensure that the leads are connected. Ensure that the cable is in good working order. Correct the ECG configuration. Replace the main board. See Removing the Main board Assembly on page 5-8 (UT4000A) or 6-21 (UT6000A). Replace the ECG module. See Removing the ECG Module on page 5-7 (UT4000A) or 6-15 (UT6000A). Ensure that the ECG leads are connected. Ensure that all external ECG reading requirements are met and that the patient is not moving excessively. Ensure proper skin preparation has been performed.

The ECG cable is broken. The ECG 3/5 lead set is not configured correctly. The main board module has malfunctioned.

The ECG module has malfunctioned.

I’m getting unreliable ECG readings

The ECG leads are off. There has been some external problem.

3.7 Respiration Problems (UT6000A only) There are no respiration readings

The respiration leads are off. The ECG module has malfunctioned.

The respiration readings are unreliable

There has been some external interference.

3-8

Ensure that the respiration leads are connected. Replace the ECG module. See Removing the ECG Module on page 6-15 (UT6000A). Ensure that all respiration reading requirements are met and that the patient is not moving excessively. Ensure that the correct ECG lead set is being used.

Troubleshooting

3.8 Temperature Problems (UT6000A only) Symptom

Possible Cause

Action

There are no temperature readings

The probe lead is off.

Ensure that the temperature probe is connected. Ensure that temperature readings are in the range of 0oC-50oC. Replace the temperature probe. Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A). Replace the temperature probe. Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A).

The temperature is over range. The probe has malfunctioned. The main board has malfunction.

I’m getting unreliable temperature readings

The probe has malfunctioned. The main board has malfunction.

3.9 Recorder Problems (UT6000A only) Symptom

Possible Cause

Action

The recorder paper is jamming

The paper is not installed correctly. The recorder is using improper paper. The recorder has a mechanical problem.

The recorder does not print

The paper is out and/or the recorder door is open.

Remove paper and reinstall correctly. Use only the recommend recorder paper. Replace the recorder. See Removing the Recorder on page 6-5 (UT6000A). Install a new paper supply. Open the recorder door, and then close it again. Check the recorder’s physical connections. See Removing the Recorder on page 6-5 (UT6000A). Replace the recorder module. See Removing the Recorder on page 6-5 (UT6000A). Replace the main board. See Removing the Main board Assembly on page 6-21 (UT6000A).

The system does not recognize the recorder.

The recorder module has malfunctioned.


3-9

Troubleshooting

3.10 Performance Verification After repairing the monitor, Performance Verification Testing is recommended. See 2.5 Performance Verification Testing.

3-10

Theory of Operation

Chapter 4 Theory of Operation

4-1

Theory of Operation This chapter overviews the operation theory of several major functional components of the UT4000A/UT6000A Patient Monitors.

4.1 System Configuration

Figure 4-1 Block Diagram (UT4000A)

ECG Module (ECG & RESP)

Speaker assembly

NIBP Module

Ethernet port (RJ45 Port)

RS422 Port (Software updating Only)

I/O module assembly

Recorder

SPO2 Module AC/DC power module AC power assembly AC socket

Main Board assembly Speaker Driver Charge control Inverter control Keys control Power supply to other modules Signals interface Temperature

Supply mains

Display assembly

Inverter

Power LED Front Panel

Battery

Battery LED Navigation wheel

Keys

Figure 4-2 Block Diagram (UT6000A)

4-2

Theory of Operation

4.2 Theory of Operation This section contains a system overview for the UT4000A/UT6000A Patient Monitors.

4.2.1 System overview The monitors are full function monitors for use on adult, pediatric, and neonatal patients. The functions performed by the system include: •

Monitoring patient ECG, heart rate and respiration rate (UT6000A only)

•

Non-invasive blood pressure

•

Blood oxygen saturation

•

Temperature (UT6000A only)

In addition to monitoring and displaying the status of physiological parameters, the monitor performs various microprocessor-programmed analytical functions, including: •

Providing both visual and audible alarm signals as necessary.

•

Providing warning messages when harmful conditions are detected that would degrade or prevent valid measurements.

• •

Providing trend waveforms or tabular data. Recording current waveforms or tabular data. (UT6000A only).

UT4000A/UT6000A Patient Monitors operate from either an AC power source or on battery power. The monitor charges the internal battery when powered by supply mains.

4.2.2 Block Diagram Components The UT4000A/UT6000A Patient Monitors contain several major blocks, including: •

Front case assembly

•

Main Board assembly

•

I/O Module assembly

•

Display assembly

In addition, the UT6000A Patient Monitor contains an optional recorder module. The following sections briefly describe the functional units in block diagrams.

4-3

Theory of Operation

4.2.3 Main Board Assembly The Main Board assembly contains the following components: •

Microprocessor

•

Flash memory

•

Power management control - Voltage regulator - Battery charger that monitor status of battery

•

LCD drivers

•

Power distribution and monitoring

•

Speaker driver

•

Connectors - DC input (wire to AC/DC module) - LCD - LCD backlight - Alarm LED - SpO2 - Temp (Temperature)

4.2.4 I/O Module The I/O Module contains the following components: •

LAN connector and isolation transformer

•

RS422 Port (SW updates only)

•

Speaker

•

ECG connector

•

NIBP connector

•

Recorder

4.2.5 Display Assembly The display assembly contains these elements: •

LCD 7 ”

•

LCD inverter

4.2.6 Speaker The speaker is driven by an amplifier connected to the microprocessor. The speaker provides an audio for alarm conditions and HP/RP sounds. The microprocessor generates different audio tones for different alarm priorities and conditions.

4-4

Theory of Operation

4.2.7 Keys and Navigation Wheel The keys generate pulses to the Main Board assembly. The navigation wheel is a rotating, push-switch wheel. The associated wheel circuitry generates a pulse when pressed and generates a digitally encoded pair of quadrature signals whose relative magnitudes and polarities represent the angular position of the wheel. These outputs are connected to the microprocessor where they are interpreted as required for the functions involved. Successive angular positions determine the direction of wheel rotation. In addition to the functions performed in conjunction with the keys, the wheel operates in conjunction with the display to select menus and lists of parameter variables.

4.2.8 AC/DC Power Module The UT6000A Patient Monitor contains a medical grade power supply module and circuitry that converts supply mains (100-240V) to DC power (15V) with 115 VA power consumption. Power Management The power management module contains: •

Lead-acid battery (12 V, 2300 mAh)

•

Battery charger

•

DC/DC converter

The power management circuitry charges a lead-acid battery through a battery charger. The battery can power the system through several DC/DC converters that provide various voltage outputs required by various chips. And the isolated transformers (external power adapter of the UT4000A patient monitor and the AC/DC power module of the UT6000A patient monitor) provide the power to the monitor. Note — The UT6000A patient monitor has a built-in AC/DC power module and the UT4000A an external power adapter. The UT6000A patient monitor can directly connect to the supply mains. However for the UT4000A monitor, a power adapter is needed connection..

4.2.9 Recorder (UT6000A only) The recorder contains the following features: •

Main components: - Digital thermal head array assembly

•

Printing width (48mm on 58mm paper)

•

Motor (paper drive) and driver circuitry

•

Dectector for running out of paper or opened recorder door

•

Selectable print speed (12.5mm/s, 25 mm/s)

Print head control is implemented on the Main Board. The microprocessor sends data to the recorder via a local BUS.

4-5

Theory of Operation

4.2.10 Processing the NIBP The NIBP assembly and circuitry contain the following elements: •

Pump

•

Valves

•

Manifold

•

Filter

•

Pressure measurement and control circuitry

Pressure data is converted to digital format and conveyed to the processor. The NIBP pump uses an oscillometric method that drives stepwise pressure deflation. Pump software eliminates most ambient noise and motion interference. It can be applied to neonatal, pediatric and adult patients. The blood pressure range for Systolic is 30-254 mmHg and Diastolic 10-220 mmHg. Accuracy is Maximum Mean Error ±5 mmHg, with Maximum Standard Deviation no greater than 8 mmHg. NIBP processing uses an oscillometric technique to provide needed measurements at selected intervals. This technique uses an inflatable sphygmomanometer cuff similar to those used by clinicians in routine measurements. A motorized pump inflates the cuff to approximately 170 mmHg (adult mode) initially, at which point the pressure effectively stops the flow of blood. Then, under monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects the pressure and transmits the parameter signal to the NIBP input circuitry. As the pressure is reduced, blood flows in the previously occluded artery, and changes the measurements made by the transducer. The point at which oscillation increases sharply is defined as systolic pressure. As the cuff continues to deflate, the oscillation amplitude increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the mean arterial pressure. The point at which the system detects a rapid decrease in oscillation is defined as the diastolic pressure.

4.2.11 Processing the SpO2 SpO2 uses an optical spectrophotometry technique to measure oxygen saturation in the blood that. It is based on the differences in the absorption of red and infrared light by oxygenated and de-oxygenated hemoglobin. A pulse oximeter passes red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle. The light sources are red and infrared light emitting

4-6

Theory of Operation diodes (LEDs). A photo diode provides detection. To identify the oxygen saturation of arterial hemoglobin, the patient monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood enters the vacuolar bed, and both blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The measurement is based on the differences between maximum and the minimum absorption. In addition to the oximetry function, the measurement can also provide the heart rate.

4.2.12 Processing the ECG The monitor measures the patient's ECG signals by sensing the varying potential difference between several points at the skin surface which respond to the electro-chemical actions of the muscular activity of the heart. Up to five electrodes are attached to the patient’s body. The varying potentials at the locations are sent to the ECG circuitry. These signals are amplified and filtered and then digitized before being transmitted to the microprocessor. The microprocessor executes algorithms to: •

Display the ECG data

•

Compute the heart rate

•

Detect a lead-off condition if one of the electrode connections is disrupted

•

Detect the presence of pacemaker signals within the QRS complex of the ECG waveform

4.2.12 Processing the Respiration (UT6000A only) The principle how the patient's RESP is measured is the same as that of the ECG. However the monitor needs a different part of the signals from the leads between several points at the skin surface tensions. These signals are amplified and filtered, and then digitized before being transmitted to the microprocessor. The microprocessor executes algorithms to: •

Display the RESP data

•

Compute the respiration rate

4.2.13 Processing the Temperature (UT6000A only) Resistance temperature detectors (RTDs) measure temperatures using the physical principle of the positive temperature coefficient of electrical resistance of metals. The hotter they become, the larger – or higher – the value of their electrical resistance. The advantage is stable outputs for long periods of time, ease of recalibration, and accurate readings over relatively narrow temperature spans. The monitor’s input circuitry conditions and processes the signal to drive the numeric display. 4-7

UT4000A System Disassembly

Chapter 5 UT4000A System Disassembly

5-1

UT4000A System Disassembly This chapter describes the procedures for disassembling and assembling the UT4000A monitor in order to replace or repair defective assemblies/components. Warning

After any monitor repair, you must perform the recommended Performance and Safety tests before putting the monitor into operation. Failure to perform those tests might result in incorrect monitor readings. For more information on performing Performance and Safety tests, see Chapter 2 Maintenance.

5.1 Service Tools The following lists the tools and additional test equipment required to disassemble, repair, and re-assemble the monitor. •

One Phillips-head screw driver Φ5mm (at least 100mm long)

•

One Phillips-head screw driver Φ3mm

•

One flat-head screw driver Φ5mm

•

One wire cutter

•

One long flat nose plier

•

One hexagon nut driver Φ5.5mm

•

One Uport 1150 transducer (purchased from Goldway)

•

ESD mat and wrist strap

5.2 Disassembly You can disassemble the monitor down to all major component parts, including: •

Printed Circuit Boards (PCBs)

•

Adapter

•

Battery

•

Cables

•

LCD

Warning Before attempting to open or disassemble the monitor, disconnect the power supply from the monitor and remove the battery. High voltage is made by the LCD backlight driver.

Caution Observe ESD (electrostatic discharge) precautions when working inside the unit.

5-2


5.3 Removing the Power Adapter 1. Disconnect the connector and power cord from the monitor to remove the power adapter.

p/n

Description

83801041000

Power Adapter 15V/3.3A

5-3


5.4 Removing the Battery Caution Before removing the battery, power off the monitor and disconnect supply mains. 1. Push the battery cover in the direction shown.

2. With one thumb pushing the battery and the other rotating the battery holder as shown, the battery will pop out automatically.

3. Remove the battery

5-4


5.5 Disassembling the Monitor 1. Remove the battery. (See Removing the Battery on page 5-4) 2. Remove the power adapter. (See Removing the Power Adapter on page 5-3), networking cable and other cables which are connected to the monitor. 3. Remove the screws. Underside

Back top 4. Separate the front and rear case by pulling the upper and lower edge of the front case.

Caution Connectors between the front case and rear case. 5. Gently pull the power module cable, I/O module cable and SpO2 module cable out of the connectors.

I/O module cable Power module

SpO2 module cable

5-5


5.6 Removing the SpO2 Module 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Removing the two screws. (Circles) 3. Pulling the SpO2 module up gently. 4. Disconnect the connector board and connect it back to main board. (Rectangle)

5. Remove the SpO2 module.

p/n

Description

83801002000

SPO2 Module

5-6


5.7 Removing the ECG Module 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Remove the ECG cables (Rectangle). 3. Remove screws. (Circles)

4. Remove the ECG module gently. p/n

Description

83801005000

ECG Module

5-7


5.8 Removing the Main board Assembly 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 1. Remove the SpO2 module. (See Removing the SpO2 Module on page 5-6) 2. Disconnect the cables. (Rectangles) 3. Remove the screws.( Circles)

4. Remove the Main board Assembly.

p/n

Description

83801050000

Main Board assembly 4A

5-8


5.9 Removing the Connectors Panel 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Disconnect the cables. (Rectangles)

3. Disconnect the tubing (The connector indicated by arrow)

4. Remove the connectors panel.

p/n

Description

83801044000

Connectors panel 4A

5-9


5.10 Removing the Inverter 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Disconnect the cables. (Rectangle) 3. Remove the screws.( Circles)

4. Remove the Inverter.

p/n

Description

83801027000

Inverter BSFI#1011-44B

5-10


5.11 Removing the Front Case Assembly 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Remove the SpO2 module. (See Removing the SpO2 module on page 5-6) 3. Remove the Main board Assembly. (See Removing the Main Board Assembly on page 5-8) 4. Remove the Inverter (See Removing the Inverter on page 5-10) 5. Retain the front case assembly 4A.

p/n

Description

83801046000

Front case assembly 4A

5-11


5.12 Separating the Rear Case 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Remove the screws. (Circles)

3. Remove the screws on the underside.

4. Disconnect the speaker cable on the top of main frame.

5. Remove the main frame from the rear case.

5-12


5.13 Removing the Speaker Assembly 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Separate the rear case. (See Separating the Rear case on page 5-12) 3. Remove the screws. (Circle) 4. Cut the tie wrap. (Rectangle)

5. Remove the speaker assembly.

p/n

Description

83801054000

Speaker assembly 4A/6A

5-13


5.14 Removing the Rear Case assembly 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Separate the rear case. (See Separating the Rear Case on page 5-12) 3. Remove the speaker assembly. (See Remove the speaker assembly on page 5-13) 4. Remove the rear case assembly.

p/n

Description

83801052000

Rear case assembly 4A

5-14


5.15 Removing the NIBP Module The NIBP module has been installed at the back of main frame. 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Separate the rear case. (See Separating the Rear case on page 5-12) 3. Disconnect the cables. (Rectangle) 4. Remove the screws. ( Circles) 5. Disconnect the tubing. (Triangle)

6. Remove the NIBP module.

p/n

Description

83801006000

NIBP Module

5-15


5.16 Removing the I/O Module Assembly 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Separate the rear case. (See Separating the Rear Case on page 5-12)

3. Remove the screws.

4. Remove the I/O module assembly 4A (or I/O module assembly 4A (with RJ45)).

p/n

Description

83801048000

I/O module assembly 4A

83801055000

I/O module assembly 4A (with RJ45)

5-16


5.17 Removing the Battery Connect Board/DC Connector 1. Disassemble the monitor. (See Disassembling the monitor on page 5-5) 2. Separate the rear case. (See Separating the Rear Case on page 5-12) 3. Remove the screws. (Rectangle and arrows)

4. Cut the tie wraps.(Circles) 5. Remove the plastic nut from connector with long flat nose plier.

6. Remove the battery connect board/DC Connector.

p/n

Description

83801042000

Battery connect Board/DC Connector 4A

5-17


Chapter 6 UT6000A System Disassembly

6-1

UT6000A System Disassembly This chapter describes the procedures for disassembling and assembling the UT6000A monitor in order to replace or repair defective assemblies/components. Warning

After any monitor repair, you must perform the recommended Performance and Safety tests before putting the monitor into operation. Failure to perform those tests might result in incorrect monitor readings. For more information on performing Performance and Safety tests, see Chapter 2 Maintenance.

6.1 Service Tools The following lists the tools and additional test equipment required to disassemble, repair, and re-assemble the monitor. •

One Phillips-head screw driver Φ5mm (at least 100mm long)

•

One Phillips-head screw driver Φ3mm

•

One flat-head screw driver Φ5mm

•

One wire cutter

•

One long flat nose plier

•

One hexagon nut driver Φ5.5mm

•

One Uport 1150 transducer (purchased from Goldway)

•

ESD mat and wrist strap

6.2 Disassembly You can disassemble the monitor down to all major component parts, including: •

Printed Circuit Boards (PCBs)

•

Recorder

•

Battery

•

Cables

•

LCD

Warning Before attempting to open or disassemble the monitor, disconnect the power supply from the monitor and remove the battery. High voltage is made by the LCD backlight driver.

Caution Observe ESD (electrostatic discharge) precautions when working inside the unit.

6-2


6.3 Removing the Battery Caution Before removing the battery, power off the monitor and disconnect supply mains. 1. Pry the battery cover from the casing with a flat-head screw driver.

2. With one thumb pushing the battery and the other rotating the battery holder as shown, the battery will pop out automatically.

3. Remove the battery

6-3


6.4 Removing Power Fuses 1. Remove the fuse socket with a Phillips head screw driver.

2. Remove the fuses.

6-4


6.5 Removing the Recorder 1. Push up the plastic plate to open the door.

2. Remove the two screws.

3. Pull the recorder straight out of the monitor and disconnect the connector.

4. Removed recorder.

p/n

Description

83801015000

Recorder 6-5


6.6 Removing the Rear Case 1. Remove the battery. (See Removing the Battery on page 6-3) 2. Remove the networking cable and other cables which are connecting to the monitor. 3. Remove the recorder. (See Removing the Recorder on page 6-5) 4. Remove the screws. Back top

Underside

5. Separate the front and rear case by pulling the upper and lower edge of the front case. Carefully move the alarm LED cover and keep it be with the front case. Carefully move the connectors panel

6-6

UT6000A System Disassembly 6. Remove the rear case.

p/n

Description

83801053000

Rear case assembly 6A

6-7


6.7 Removing the Connectors Panel 1. Remove the battery. (See Removing the Battery on page 6-3) 2. Remove the recorder. (See Removing the Recorder on page 6-5) 3. Remove the rear case. (See Removing the Rear Case on page 6-6) 4. Disconnect the cables. (Rectangles) 5. Disconnect the tubing. (Circle)

6. Remove the connectors panel. Face

Back

p/n

Description

83801045000

Connectors panel 6A 6-8


6.8 Disassembling the Main Frame 1. Remove the battery. (See Removing the Battery on page 6-3) 2. Remove the recorder. (See Removing the Recorder on page 6-5) 3. Remove the rear case. (See Removing the Rear Case on page 6-6) 4. Loosen the lock screws.

5. Carefully to disconnect the cables and cut the tie wrap.

6. Separate the front case from the main frame.

6-9


6.9 Removing the Ports Frame 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the screws. (Circles)

3. Disconnect speaker connector. (Circle)

4. Disconnect ECG connector. (Circle)

6-10

UT6000A System Disassembly 5. Disconnect main board power cable. (Circle)

6. Remove the ports frame.

6-11


6.10 Removing the Speaker 1. Remove the ports frame. (See Disassembling the Ports Frame on page 6-10) 2. Remove the speaker from main frame.

p/n

Description

83801054000

Speaker assembly 4A/6A

6-12


6.11 Removing the I/O module assembly 1. Remove the ports frame. (See Disassembling the Ports Frame on page 6-10) 2. Remove the screws.

3. Remove the I/O module from the ports frame.

p/n

Description

83801049000

I/O module assembly 6A

83801056000

I/O module assembly 6A (with RJ45)

6-13


6.12 Disassembling the AC power assembly 1. Remove the ports frame. (See Disassembling the Ports Frame on page 6-10) 2. Remove the I/O module assembly. (See Removing the I/O module assembly on page 6-13) 3. The remaining part of the ports frame is the AC power assembly.

p/n

Description

83801040000

AC power assembly 6A

6-14


6.13 Removing the ECG Module 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the screws. (Circles) 3. Disconnect the ECG connector. (Rectangle)

4. Remove the ECG module. p/n

Description

83801005000

ECG Module

6-15


6.14 Removing the NIBP Module 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Disconnect the tubing.

(Triangle)

3. Disconnect the NIBP module connector. (Rectangle)

4. Remove screws. (Circles) 5. Remove the NIBP module. p/n

Description

83801006000

NIBP Module

6-16


6.15 Removing the AC/DC Power Module 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the ports frame. (See Removing the Ports Frame on page 6-10) 3. Disconnect the connector. (Rectangle) 4. Remove the screws. (Circles)

5. Remove the AC/DC Power Module. p/n

Description

83801008000

AC/DC Power Module

6-17


6.16 Removing the Battery Connect Board 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the Ports frame. (See Removing the Ports Frame on page 6-10) 3. Cut the tie wraps at the bottom. (Circles)

4. Remove the screws. (Circles)

5. Remove the battery connect board.

p/n

Description

83801043000

Battery connect board 6A

6-18


6.17 Removing the Inverter 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Disconnect the cables. (Rectangles) 3. Remove the screws. (Circles)

4. Remove the Inverter.

p/n

Description

83801027000

Inverter BSFI#1011-44B

6-19


6.18 Removing the SpO2 module 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the screws. (Circles)

3. Remove the SpO2 module. 4. Disconnect the connector board (Rectangle) and connect it back to the main board.

p/n

Description

83801002000

SpO2 Module

6-20


6.19 Removing the Main board Assembly 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the SpO2 module. (See Removing the SpO2 module on page 6-20) 3. Disconnect the cables. (Rectangles) 4. Remove the screws. (Circles)

5. Remove the main board.

p/n

Description

83801051000

Main Board assembly 6A

6-21


6.20 Removing the Front Case Assembly 1. Disassemble the main frame. (See Disassembling the Main Frame on page 6-9) 2. Remove the SpO2 module. (See Removing the SpO2 module on page 6-20) 3. Remove the main board. (See Removing the Main board Assembly on page 6-21) 4. The remaining part is the front case assembly.

p/n

Description

83801047000

Front case assembly 6A

6-22

Electromagnetic Compatibility

Appendix A Electromagnetic Compatibility

A-1


A.1 Instructions for use Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC60601-1-2:2004, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1- 2:2004. Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your service provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in this manual. Warning

Use of accessories, transducers, and cables other than those specified may result in increased emissions and/or decreased immunity of the UT4000A/UT6000A Patient Monitors. UT4000A/UT6000A Patient Monitors should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it is used.

Caution

The following ports on UT4000A/UT6000A Patient Monitors are sensitive to electrostatic discharge during patient monitoring: • SpO2 • ECG Follow these guidelines to reduce electrostatic discharge: • Do not touch the connector pins of the port. • When connecting and disconnecting cables to the ports, use ESD precautionary measures. Precautionary measures may include the following: – Make sure you are grounded prior to connection. Touch grounded metal. – Wear an ESD grounding strap and an ESD protective garment.

–

Provide ESD training to all users. Users should understand what electrostatic discharge is, how damage can occur, and how to prevent ESD.

A-2


A.2 Guidance and Manufacturer's EMC Declaration The UT4000A/UT6000A Patient Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of the UT4000A/UT6000A Patient Monitors should assure that it is used in such an environment.

A.2.1

Electromagnetic Emissions for all Equipment and Systems Table A-1 Electromagnetic Emissions-for All Equipment and Systems

Emission test

Compliance

Electromagnetic Environment – Guidance

RF emissions

The UT4000A/UT6000A Patient Monitors use

CISPR 11

RF energy only for its internal function. Group 1

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11 Harmonic emissions IEC 61000-3-2

The UT4000A/UT6000A Patient Monitors are

Class A

suitable for use in all establishments, other than domestic establishments and those directly

Class A

connected to the public low-voltage power supply network that supplies buildings used for

Voltage fluctuations/ flicker emissions

domestic purposes.

Complies

IEC 61000-3-3

A.2.2

Electromagnetic Immunity for all Equipment and Systems Table A-2 Electromagnetic immunity –for all Equipment and Systems

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic

±6 kV contact

±6 kV contact

Floors should be wood,

discharge (ESD)

±8 kV air

±8 kV air

concrete or ceramic tile. If

IEC 61000-4-2

floor are covered with synthetic material, the relative humidity should be at least 30%.

A-3

Electromagnetic Compatibility Table A-2 Electromagnetic immunity –for all Equipment and Systems(Continuous)

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrical fast

±2 kV for power

±1kV for

Mains power quality should

transient/burst

supply lines

power supply

be that of a typical

lines

commercial or hospital

IEC 61000-4-4

environment. It recommends the use of filters on power input lines. Surge

±1 kV

±1 kV


IEC 61000-4-5

Differential

differential mode


mode

±2 kV


±2 kV common

common mode

environment.

mode Voltage dips,

<5% UT1

<5% UT


short

(>95% dip in UT)

(>95% dip in UT)


interruptions

for 0.5 cycle

for 0.5 cycle


and voltage

environment. If the user of

variations on

40% UT

40% UT

the UT4000A/UT6000A

power supply

(60% dip in UT)

(60% dip in

Patient Monitors requires

input lines

for 5 cycles

UT)for 5 cycles

continued operation during

IEC 61000-4-11

power mains interruptions. It 70% UT

70% UT

is recommended that the

(30% dip in UT)

(30% dip in UT)

UT4000A/UT6000A Patient

for 25 cycles

for 25 cycles

Monitors be powered from an uninterruptible power

Power

<5% UT

<5% UT

(>95% dip in UT)

(>95% dip in UT)

for 5 sec

for 5 sec

3A/m

3A/m

supply or a battery.

Power frequency magnetic

frequency

fields

(50/60Hz)

Should be at levels

magnetic field

characteristic of a typical

IEC61000-4-8

location in a typical commercial or hospital environment.

1. UT is the AC mains voltage prior to application of the test level.

A-4


A.2.3

Electromagnetic Immunity for Equipment and Systems not Life-Supporting Table A-3 Electromagnetic immunity –for Equipment and Systems not Life-Supporting

Immunity test

IEC 60601 test Compliance level level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the UT4000A/UT6000A Patient Monitors, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80

3 Vrms

MHz Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5

3 V/m

GHz

⎡ 3.5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦ ⎡ 3.5 ⎤ d =⎢ ⎥ P ⎣ E1 ⎦ ⎡7⎤ d =⎢ ⎥ P ⎣ E1 ⎦ Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

a.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the UT4000A/UT6000A A-5

Electromagnetic Compatibility Patient Monitors are used exceeds the applicable RF compliance level above, the UT4000A/UT6000A Patient Monitors should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the UT4000A/UT6000A Patient Monitors. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

A.2.4

Recommended Separation Distances The UT4000A/UT6000A Patient Monitors are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the UT4000A/UT6000A Patient Monitors can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the UT4000A/UT6000A Patient Monitors as recommended below, according to the maximum output power of the communications equipment. Table A-4 Recommended separation distances between portable and mobile RF communications equipment and UT4000A/UT6000A Patient Monitors

Separation distance according to frequency of transmitter(m)1 Rated maximum

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5

output power of

⎡ 3.5 ⎤ d =⎢ ⎥ P ⎣ V1 ⎦

⎡ 3.5 ⎤ d =⎢ ⎥ P ⎣ E1 ⎦

GHz

0.01

0.12

0.12

0.23

0.1

0.37

0.37

0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

transmitter (W)

1.

⎡7⎤ d =⎢ ⎥ P ⎣ E1 ⎦

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note —

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

A-6

Electromagnetic Compatibility The following interference test results do not affect patient diagnoses. Table A-5 Interference phenomena

Immunity IEC 60601 test Compliance level Phenomena test level Electrical

±2 kV for power

1kV for power

Adding ±2KV interference

fast

supply lines

supply lines

to the power supply line

transient/

heavily interfered with the

burst

ECG waveform.

IEC

Decreasing interference to

61000-4-4

±1KV slightly interfered with the waveform. Removing the interference returned the waveform to the previous operating mode within 10 seconds with no loss of stored data.

A-7

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1.0 1.0

UT4000AUT6000A Patient Monitors Service Guide

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